PowerPICC Provena S1193108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741130359), received between Apr 8, 2020 and Jun 23, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT WHILE PLACING A PICC LINE, WHEN UTILIZING THE INTRODUCER TO DILATE, THE PATIENT REPORTED PAIN WHEN DILATING EVEN THOUGH LIDOCAINE WAS SUFFICIENTLY USED. WHEN DILATOR WAS REMOVED IT WAS NOTICED THE DAMAGE TO THE SHEATH WHERE IT HAD BUCKLED/BENT AND BECAME SHARP, THIS WAS THEN REPLACED WITH A NEW INTRODUCER WITH NO ISSUES.

  Patient problems: Pain

  MAUDE report 22311682 ↗
• MalfunctionOct 11, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT, "PLACING POWER PICC CATHETER REMOVING INTERNAL WIRE, TIP SHEARED WHEN REMOVING THROUGH VALVE OF CATHETER HUB. BLOOD ASPIRATED BACK AND ABLE TO RETRIEVE AND IDENTIFY TIP OF WIRE. PICC EXCHANGED FOR NEW PICC. PATIENT ASSESSED AFTER EVENT, NO SYMPTOMS OF FOREIGN BODY. DURING REINSERTION OF NEW PICC, NORMAL SINUS RHYTHM PRESENT ON MONITOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584418 ↗
• MalfunctionApr 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE PICC LINE KINKED IN ARM OF THE PATIENT. PATIENT RECEIVE ALTEPLASE, ADDITIONAL CHEST X-RAYS, AND REQUIRED ADDITIONAL PICC PLACEMENT. ADDITIONAL INFO. RECEIVED 04/07/2021: WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? BARD PICC STAT LOCK AND 3M TEGADERM IV ADVANCED SECUREMENT PLACEMENT DATE: (B)(6) 2021 EXPLANT DATE: (B)(6) 2021 A DETAILED DESCRIPTION OF THE EVENT: PICC CURLED INTERNALLY, PICC HAD TO BE REPLACED WAS THERE ANY PATIENT HARM REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641991 ↗
• MalfunctionMar 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "I WAS JUST PLACING A SL 3FR AND THE INTRODUCER THAT WAS IN THE KIT HAD A BARB ON THE TIP OF THE GRAY DILATOR PART BEFORE I EVEN ATTEMPTED TO INSERT IT." ADDITIONAL INFORMATION RECEIVED 02/26/2021 "WAS THERE ANY PATIENT HARM REPORTED? NO, A GRAY KIT WAS DROPPED AND THE LINE PLACED WITHOUT INCIDENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530060 ↗
• MalfunctionMar 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT TWO INTRODUCER SHEATHS CURLED UP AT THE END WHEN TRYING TO INSERT. ADDITIONAL INFO. RECEIVED 02/26/2021 "WAS THERE ANY PATIENT HARM REPORTED? NO, A GRAY KIT WAS DROPPED AND THE LINE PLACED WITHOUT INCIDENT." THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530058 ↗
• MalfunctionMar 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT TWO INTRODUCER SHEATHS CURLED UP AT THE END WHEN TRYING TO INSERT. ADDITIONAL INFO. RECEIVED 02/26/2021 "WAS THERE ANY PATIENT HARM REPORTED? NO, A GRAY KIT WAS DROPPED AND THE LINE PLACED WITHOUT INCIDENT." THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530057 ↗
• MalfunctionNov 12, 2020Defective Component; Defective Component; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON A 3 FRENCH SINGLE LUMEN PICC THE MARKINGS INDICATING PLACEMENT ARE WEARING OFF AFTER A FEW DRESSING CHANGES. THE ZERO ON THE PICC LINE HAS ALMOST WORN OFF. IT WAS STATED THAT THIS IS A CONCERN, AS IT BECOMES DIFFICULT TO ENSURE THAT A PICC LINE IS STILL CENTRAL WITH DRESSING CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10830293 ↗
• MalfunctionJun 24, 2020Defective Component; Defective Component

  IT WAS REPORTED "WE ARE NOTICING WITH THE 3 FRENCH SINGLE LUMEN PICCS THE MARKINGS INDICATING PLACEMENT ARE WEARING OFF AFTER A FEW DRESSING CHANGES. THIS IS A CONCERN, AS IT BECOMES DIFFICULT TO ENSURE THAT A PICC LINE IS STILL CENTRAL WITH DRESSING CHANGES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10189080 ↗
• MalfunctionApr 14, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING A PICC PLACEMENT. THE NURSE PLACING THE PICC WAS ABLE TO USE THE DILATOR WITHOUT ANY DIFFICULTY, BUT HAD DIFFICULTY WHEN ATTEMPTING TO ADVANCE WITH MICROINTRODUCER THROUGH THE SKIN. THE MICROINTRODUCER WAS FLIMSY AND APPEARED TO CRINKLE DURING ATTEMPTS TO ADVANCE IT. THE NURSE ALSO USED THE SCALPEL TO NICK THE SKIN TO TRY TO ADVANCE THE MICRO INTRODUCER (SOMETHING WE RARELY HAVE TO DO ANYMORE). THE NURSE ULTIMATELY HAD TO USE A MICROINTRODUCER FROM A MINI STICK KIT. MINOR DAMAGE WAS OBSERVED TO THE MICROINTRODUCER, BUT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959076 ↗
• MalfunctionApr 8, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE WAS DIFFICULTY PLACING 2 POWERPICC PROVENA SOLO SL. REPORTED THAT THE INTRODUCER FELT FLIMSY AND AFTER ONE DIFFICULT PLACEMENT WHERE THEY HAD TO MANIPULATE THE DILATOR MULTIPLE TIMES AND OBSERVED THE TIP OF THE INTRODUCER WAS ¿CHEWED UP¿ AND MANGLED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9937645 ↗
• MalfunctionApr 8, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE WAS DIFFICULTY PLACING 2 POWERPICC PROVENA SOLO SL. REPORTED THAT THE INTRODUCER FELT FLIMSY AND AFTER ONE DIFFICULT PLACEMENT WHERE THEY HAD TO MANIPULATE THE DILATOR MULTIPLE TIMES AND OBSERVED THE TIP OF THE INTRODUCER WAS ¿CHEWED UP¿ AND MANGLED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9937611 ↗